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Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial (ML-AKI)

2026年5月19日 更新者:University of California, San Francisco

Prediction of Acute Kidney Injury (AKI) After Surgery: A Pragmatic Three-Arm Cluster-Randomized Trial

This investigator-initiated, pragmatic trial evaluates whether displaying a machine learning (ML)- derived perioperative AKI risk score-alone or paired with an interruptive Best/Our Practice Advisory (BPA/OPA)-improves kidney-protective care and reduces kidney injury after non-obstetric surgery at UCSF. Approximately 75-100 attending anesthesiologists (clusters) are randomized 1:1:1 to: (a) Control (risk score hidden), (b) Score Only (visible preoperative AKI risk probability with passive KDIGO bundle recommendation), or (c) Score + BPA (visible risk plus interruptive KDIGO prompt for high-risk patients). CRNAs/residents follow their attending' s assignment. Adult inpatients (age ≥18) with expected overnight stay and eGFR ≥15 mL/min/1.73 m² are included; obstetrics, chronic dialysis, and kidney transplant patients are excluded. The underlying preoperative model was prospectively validated at UCSF and outperforms anesthesiologist risk estimation reported in the literature. The model was reviewed and approved by the AI Oversight Committee at UCSF. Primary endpoint is the continuous change in serum creatinine (mg/dL) from baseline to POD 1-2. Secondary outcomes include KDIGO-defined AKI, adherence to bundle elements (hemodynamics, balanced fluids, nephrotoxin avoidance, glycemic control), intraoperative hypotension time, fluid volumes, nephrotoxin exposure, perioperative hyperglycemia, length of stay, unplanned ICU transfer, readmission, dialysis, and in-hospital mortality. Data are obtained from the EHR; analysts are blinded. No direct subject interaction is planned; the investigators will request a waiver of patient consent. The study aims to demonstrate that ML-enabled, workflow-embedded decision support can safely and feasibly improve guideline concordant care and decrease early postoperative kidney injury.

調査の概要

研究の種類

介入

入学 (推定)

25518

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • California
      • San Francisco、California、アメリカ、94158
        • University of California, San Francisco

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • Adults ≥18 years undergoing non-obstetric surgery at UCSF.
  • Inpatient cases with expected overnight stay.
  • Baseline eGFR ≥15 mL/min/1.73 m².
  • Managed by an attending anesthesiologist randomized to one of three arms (CRNAs/residents follow attending).
  • Data available in the UCSF EHR for risk scoring and outcomes.

Exclusion Criteria:

  • Obstetric procedures.
  • Chronic dialysis patients.
  • Kidney transplant recipients.
  • Cases without baseline creatinine/eGFR or missing essential EHR elements needed for scoring/outcomes (operational exclusions).
  • Outpatient procedures without expected overnight stay.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ふるい分け
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Control Arm
Participants receive usual perioperative care with a placeholder blank display without the machine learning-derived acute kidney injury (AKI) risk score. The clinical decision support tool remains hidden in the electronic health record, and no alerts or recommendations related to the study are shown.
実験的:Acute Kidney Injury Risk Score Only
A machine learning-derived preoperative AKI risk score is displayed within the electronic health record for high-risk patients. A passive recommendation indicating that the patient may benefit from a KDIGO-based kidney-protective bundle is provided. The information is advisory only, and no interruptive alerts are used.
A non-adaptive, machine learning-based clinical decision support tool integrated into the electronic health record that generates a preoperative probability of acute kidney injury (AKI) using routinely collected patient data. For patients identified as high risk, the tool displays the risk estimate to anesthesia providers without an accompanying Best Practice Advisory (BPA) recommending consideration of a KDIGO-based kidney-protective bundle. The intervention is advisory only, does not mandate clinical actions, and is designed to support provider decision-making within the existing clinical workflow.
他の名前:
  • EHR-Embedded AKI Clinical Decision Support Tool
実験的:Acute Kidney Injury Risk Score with Best Practice Advisory
The machine learning-derived AKI risk score is displayed within the electronic health record for high-risk patients, accompanied by an interruptive Best Practice Advisory (BPA) that notifies providers that the patient may benefit from a KDIGO-based kidney-protective bundle. The alert is advisory only and does not mandate clinical actions.
A non-adaptive, machine learning-based clinical decision support tool integrated into the electronic health record that generates a preoperative probability of acute kidney injury (AKI) using routinely collected patient data. For patients identified as high risk, the tool displays the risk estimate to anesthesia providers with an accompanying Best Practice Advisory (BPA) recommending consideration of a KDIGO-based kidney-protective bundle. The intervention is advisory only, does not mandate clinical actions, and is designed to support provider decision-making within the existing clinical workflow.
他の名前:
  • EHR-Embedded AKI Clinical Decision Support Tool

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Post-operative Change in Creatinine
時間枠:From pre-operative baseline to 1-2 days post-operative level
Maximum continuous change in serum creatinine (mg/dL) from baseline to post-operative day 1-2
From pre-operative baseline to 1-2 days post-operative level

二次結果の測定

結果測定
メジャーの説明
時間枠
Acute Kidney Injury
時間枠:Operation to Post-operative Day 7
Acute Kidney Injury as defined by KDIGO
Operation to Post-operative Day 7
KDIGO Bundle Adherence
時間枠:Intra-operative
Measurement of provider adherence to KDIGO components
Intra-operative
Intra-Operative Time and Severity of Hypotension
時間枠:Intra-operative
Intra-Operative Time and Severity (meaning how far below the threshold) where patient is in hypotension, defined as systolic blood pressure <90 mmHg and mean arterial pressure <65 mmHg during surgery
Intra-operative
Total intra-operative intravenous fluid volume administered (mL)
時間枠:Intra-operative
Provider administration of intravenous fluids during the intra-operative period, measured in milliliters (mL). Intravenous fluids include normal saline, lactated Ringer's, Plasma-Lyte, other balanced crystalloids, and colloid solutions such as albumin.
Intra-operative
Length of Stay
時間枠:Operation to Post-operative Day 180
Duration of patient admission in hospital in days
Operation to Post-operative Day 180
Intra-operative Hyperglycemic Events
時間枠:Intra-operative
Number of intra-operative hyperglycemic events, defined as the number of recorded blood glucose measurements exceeding 180 mg/dL.
Intra-operative
Intra-operative Nephrotoxin Exposure
時間枠:Intra-operative
Number of nephrotoxic medications administered intra-operatively and duration of intra-operative exposure
Intra-operative
In-Hospital Mortality
時間枠:Operation to Post-operative Day 180
Patient death while admitted in the hospital
Operation to Post-operative Day 180
ICU Transfer and total time in the ICU
時間枠:Postoperative
Any transfers to the ICU while admitted and the total time the patient spends in the ICU
Postoperative
Hospital Readmission
時間枠:Operation to Post-operative Day 180
Readmission back to a UCSF hospital following operation
Operation to Post-operative Day 180
Dialysis Requirement
時間枠:Operation to Post-operative Day 180
Patients requiring dialysis following surgery
Operation to Post-operative Day 180
Dilution Corrected KDIGO AKI measurement (Stage 1 or higher)
時間枠:AKI is defined per KDIGO as corrected creatinine increase ≥0.3 mg/dL within 48 hours or ≥1.5× baseline within 7 days. This measure captures "hidden AKI" - kidney injury masked by fluid dilution that would be missed using standard uncorrected creatinine.

Acute kidney injury (AKI) assessed using KDIGO creatinine criteria applied to dilution-corrected postoperative serum creatinine. Creatinine is corrected for hemodilution from perioperative fluid retention using the formula:

Corrected Creatinine (mg/dL) = Measured Creatinine × (1 + Net Fluid Balance / Total Body Water)

Where:

  • Net Fluid Balance (L) = Fluid inputs - urine output - blood loss - other outputs
  • Total Body Water (L) = 0.6 × weight (kg) for males; 0.5 × weight (kg) for females
AKI is defined per KDIGO as corrected creatinine increase ≥0.3 mg/dL within 48 hours or ≥1.5× baseline within 7 days. This measure captures "hidden AKI" - kidney injury masked by fluid dilution that would be missed using standard uncorrected creatinine.
Total intra-operative packed red blood cells administered (units transfused)
時間枠:intraoperative
Provider administration of packed red blood cells during the intra-operative period, measured as total units transfused.
intraoperative
Total intra-operative fresh frozen plasma administered (units transfused)
時間枠:intraoperative
Provider administration of fresh frozen plasma during the intra-operative period, measured as total units transfused.
intraoperative
Total intra-operative platelets administered (units transfused)
時間枠:intraoperative
Provider administration of platelets during the intra-operative period, measured as total units transfused.
intraoperative
Total intra-operative cryoprecipitate administered (units transfused)
時間枠:intraoperative
Provider administration of cryoprecipitate during the intra-operative period, measured as total units transfused.
intraoperative

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Andrew Bishara, MD、University of California, San Francisco

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月15日

一次修了 (推定)

2027年10月15日

研究の完了 (推定)

2027年12月15日

試験登録日

最初に提出

2026年4月9日

QC基準を満たした最初の提出物

2026年5月19日

最初の投稿 (実際)

2026年5月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月22日

QC基準を満たした最後の更新が送信されました

2026年5月19日

最終確認日

2026年5月1日

詳しくは

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